A New Task Force Promises to Cut Through Emergency Diagnostics Clutter

The diagnostics space just had a pretty significant week. From strong data to key product launches, the space saw a substantial amount of activity. It could be argued the spike in activity and timing of some of the announcements was spurred on by the reveal of a newly-formed task force comprised of FDA, Centers for Disease and Control, and the Centers for Medicare and Medicaid Services. The goal of the task force is to help make diagnostics rapidly available during public health emergencies. T2 Biosystems was the latest to make waves in the industry with news that it had obtained “Breakthrough Device” designation for its T2Resistance Panel. The Lexington, MA-based company’s diagnostic panel can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture. Several of the genes detected by the panel are listed on the CDC’s Urgent Threatlist for antibiotic resistance. “The T2ResistancePanel is similar to our other tests, the T2Bacteria Panel and the T2Candida Panel,” Tom Lowery, Phd, CSO of T2 Biosystems, told MD+DI. “All are operated on the T2Dx instrument powered by T2 Magnetic Resonance Technology (T2MR), and the key is that these tests are performed directly from unprocessed blood, without the need or wait for blood culture. As a result of this method, the T2Resi...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news